The first year after childbirth is a critical yet insufficiently monitored period for parental health. Postpartum mental and physical morbidity can affect both mothers and co-parents, but national longitudinal data remain scarce. The Stress Of Co-parents Related to A Traumatic Experience of birth across Switzerland (SOCRATES) cohort study aims to describe maternal and co-parental health and well-being trajectories during the first year after childbirth.

SOCRATES is a prospective, population-based cohort study conducted in all linguistic regions of Switzerland. Eligible participants include women aged 14 and above who gave birth to a live or stillborn infant (≥22⁺⁰ weeks’ gestation and ≥500 g) and their cohabiting co-parents, provided they speak German, French, Italian or English. Recruitment was conducted in 81 of the 112 Swiss maternity units, birth centres and organisations of midwives over 6 weeks in spring 2025. Clinical data on pregnancy, childbirth and the early postpartum period are extracted from medical records. Postpartum hospitalisation data are obtained through linkage with national medico-administrative databases. Participants complete online questionnaires shortly after birth and at 2, 6 and 12 months post partum, including sociodemographic characteristics and patient-reported outcomes. The primary outcome is the prevalence of childbirth-related post-traumatic stress disorder at 2 months, assessed using the City Birth Trauma Scale. Secondary outcomes include depression, physical recovery, sexual health, quality of life, healthcare use, perceived care quality and overall well-being. A weighting procedure will be used to ensure representativeness and to account for attrition.

Ethical approval was granted by all seven Swiss ethics committees (number 2024-02262). All participants provided informed consent. Findings will be disseminated through national and international conferences, peer-reviewed publications, policy briefs, social media and stakeholder engagement activities.

NCT06886841.

Area-based measures of socioeconomic status (SES) are increasingly used to study health disparities among people living with HIV (PLWH), with wide variation in how they are defined and applied across studies and settings. This study synthesises the types of area-based measures of SES used in Canada and the USA, the domains captured and their associations with health outcomes among PLWH.

A scoping review of studies published in English between 2012 and 2025 was conducted using PubMed and Web of Science. The search combined ‘HIV’ with terms related to area-based SES measures. Eligible studies included PLWH, were based in Canada or the USA, used area-based SES measures and assessed health outcomes.

We screened 3470 studies: 56 met inclusion criteria. Most were US-based (n=53) and focused solely on PLWH (n=46). Area-based SES was measured using composite (n=34), single (n=16) or both types of indicators (n=6), all drawn from census data. The most common SES domain was income/poverty (n=56), the most common geographic unit was census tract (n=19) and the most common health outcome assessed was viral load/suppression (n=29). Most studies linked lower area-based SES with poorer health outcomes among PLWH (n=46).

Our findings highlight the utility of area-based SES as an individual-level SES proxy and tool for capturing broader social determinants of health when assessing a range of health outcomes across studies including PLWH. This review contributes to strengthening methodological approaches and supports future work focused on addressing social determinants and advancing health equity for PLWH.

This scoping review identifies existing registries collecting data on Klinefelter’s syndrome (KS) patients and what data are collected, with the purpose of identifying any KS-specific registries. Findings to be used to inform future registry development.

A comprehensive scoping review was conducted. Multiple sources were reviewed and articles screened based on inclusion criteria and exclusion criteria.

Searches performed across multiple sources including PubMed, Embase, the Cochrane Library, WHO International Clinical Trials Registry Platform, Orphanet, EU Clinical Trials Register, King’s College London Library and charity organisation webpages.

The included studies were required to focus on KS patients with reported data from an active registry that routinely collects data on KS patients.

Basic information about registries identified in included articles was extracted. Registries identified were contacted with a standardised set of questions to collect additional contextual information. Findings are presented in tables.

The scoping review included 18 articles. From those, 10 registries storing KS patient data were identified. Only one of those registries was KS-specific. Only three out of 10 registries collected data that encompassed genetic, clinical and social variables. Most data included in registries were collected exclusively from medical records, although some registries included data from patient surveys. Registries that received government funding had more KS participants than those that did not.

With only one KS-specific registry existing worldwide and none within the UK, this review has identified a need for the development of further KS-specific registries. Data collected could be used to develop an accurate KS phenotype and therefore lead to increased diagnosis of the disorder, improving the lives of people with KS.

To summarise the evidence on long-term and infrequent harms following selected spinal and paraspinal injections and denervation procedures for chronic non-cancer spine pain.

Systematic review and meta-analysis.

MEDLINE, EMBASE and Cumulative Index to Nursing and Allied Health Literature from inception to October 2023.

Non-randomised studies reporting on harms of selected interventional procedures administered to adults living with chronic axial or radicular non-cancer spine pain with ≥4 weeks of follow-up.

A parallel guideline panel provided input on the scope, design and interpretation of this systematic review, including selection of adverse events for consideration. Systematic literature screening, data abstraction and risk of bias appraisal were conducted independently and in duplicate by pairs of reviewers. We used random-effects models for all meta-analyses and the Grading of Recommendations Assessment, Development and Evaluation approach to evaluate the certainty of evidence.

We included 60 longitudinal studies (56 non-comparative, 4 comparative) that enrolled 4966 patients with chronic non-cancer spine-related pain. 31 studies investigated radiofrequency ablation or denervation, 22 epidural injections and 11 joint injections or nerve blocks. Low certainty evidence suggests that joint targeted steroid injection and epidural steroid injection for chronic spine pain may result in temporary altered level of consciousness (incidence: 2.1%; 95% CI 1.1% to 4.0%), joint radiofrequency nerve ablation, joint targeted steroid injection and epidural injection of local anaesthetic and steroids may result in deep infection (incidence: 0.7%; 95% CI 0.3% to 2.0%), epidural steroid injection, joint radiofrequency nerve ablation and joint targeted injection of local anaesthetic and steroids may result in dural puncture (incidence: 1.4%; 95% CI 0.5% to 4.3%), and dorsal root ganglion radiofrequency and joint radiofrequency nerve ablation with or without joint-targeted injection of steroids may result in prolonged pain or stiffness (incidence: 8.6%; 95% CI 6.3% to 11.6%). Several interventional procedures may result in metabolic complications and prolonged sensory deficits, but the supporting evidence was only very low certainty. Most complications resolved spontaneously or with conservative management.

Low certainty evidence suggests that several common interventional procedures for chronic spine pain show risk of deep infection, dural puncture, temporary altered level of consciousness and prolonged pain or stiffness. Other harms are uncertain due to very low certainty evidence, and catastrophic outcomes were not reported in the small studies that contributed to our analyses.

The growing advancement of innovative stem cell technologies requires careful evaluation of their economic, clinical and societal impacts. Early economic evaluations are essential for developing new medical technologies and supporting key decisions about commercialisation and market access. This scoping review explores Early Health Technology Assessment (eHTA) approaches specifically related to human stem cell technologies. By examining how eHTA can support the commercialisation of these therapies, we aim to clarify its role in optimising resource allocation and enhancing both the clinical and societal benefits of stem cell technologies.

To explore the use of eHTA in the development of stem cell-related technologies, a scoping review will follow the Preferred Reporting Items for Systematic Reviews and Meta-Analyses - Scoping Review Extension guidelines. Systematic searches were conducted across scientific databases (MEDLINE, International HTA database, EconLit, PAIS Index and EconPapers), grey literature sources (Overton) and through hand-searching to identify eligible articles published from inception to 14 April 2026. No limits were imposed on language. Reviewers will independently record data from eligible studies using a standard data abstraction form. The gathered information will be synthesised both quantitatively and narratively.

Formal ethical approval is not required, as this study does not involve the collection of primary data. The findings will be shared through professional stem cell networks, published in national and international health technology assessment conference proceedings and submitted for open-access, peer-reviewed publication.

To determine the prevalence and clinical characteristics associated with polyneuropathy in kidney transplant recipients (KTRs).

Cross-sectional study.

SENS study at the University Medical Center Groningen, the Netherlands, December 2021–May 2023.

KTR, participating in the ongoing TransplantLines Biobank and Cohort Study, ≥12 months post-transplantation.

Participants underwent a structured neurological assessment including history taking, neurological examination, quantitative sensory testing and nerve conduction studies. An expert panel classified participants into no/possible, probable/definite large fibre polyneuropathy or small fibre neuropathy. Large-fibre subtypes included axonal or demyelinating, pure sensory, pure motor and sensorimotor. To assess potential associations with clinical characteristics, logistic regression analysis was conducted.

We included 160 KTRs with a mean age of 59.8±11.6 years at a median of 6.1 (95% CI 3.9 to 13.1) years post-transplantation, with 16 KTRs (10%) diagnosed with polyneuropathy before study inclusion. In total, 84 KTRs (53%) were identified with large fibre polyneuropathy and 7 KTRs (4%) with small fibre neuropathy. KTRs with large fibre polyneuropathy presented with either sensor-predominant polyneuropathy (40 KTR (48%)) or sensorimotor polyneuropathy (44 KTR (52%)). We found no neurophysiological characteristics of demyelination. Overall, 18% (95% CI 11% to 27%) of KTRs with large fibre polyneuropathy were asymptomatic. Higher age (OR=1.04 (1.01 to 1.08), p=0.01), male sex (OR=2.55 (1.19 to 5.60), p=0.02), diabetes (OR=5.58 (1.36 to 38.14), p=0.03) and elevated urea levels (OR=1.12 (1.04 to 1.23), p=0.01) were significantly associated with polyneuropathy in KTR.

In contrast with previous studies, axonal sensory or sensorimotor polyneuropathy is highly prevalent and often underdiagnosed in KTR. Next to higher age and male sex, it was independently associated with diabetes and higher urea levels. Further research is needed to reveal the aetiology and course of polyneuropathy in KTRs.

NCT04664426.

The initiation of buprenorphine for patients with opioid use disorder (OUD) in the emergency department (ED) has been associated with improved outcomes including reduced ED visits and increased treatment engagement. Though both standard-dose (8 mg buprenorphine equivalent) and high-dose (24 mg buprenorphine equivalent) strategies to initiate buprenorphine have been used in the ED, no prospective trials comparing outcomes among patients receiving these treatments have been reported.

This multisite randomised clinical trial is a multisite double-blind, double-dummy, randomised clinical trial enrolling 360 emergency department patients with moderate-to-severe OUD. Enrolled patients will be randomised to one of two study arms: standard-dose induction or high-dose induction, both provided in the ED. This study will engage, train and provide resources to five EDs throughout the US to recruit patients with untreated OUD into a randomised clinical trial. The primary aim is to evaluate the effects of the standard-dose induction and high-dose induction on rates of OUD treatment participation within 10 days post-randomisation. The secondary aims are to evaluate differences between standard-dose induction and high-dose induction on the outcomes of opioid craving, opioid withdrawal symptoms and illicit drug use assessed during 10 days post randomisation and evaluate the effects between treatment arms on rates of OUD treatment participation within 30 days post randomisation.

This study is funded by the National Institute on Drug Abuse and has been approved by the WCG Instutitional Review Board. It has been registered at clinicaltrials.gov. This study will inform the strategy for treatment initiation with buprenorphine among diverse ED settings and will provide ongoing evidence to support the safety and efficacy of initiating treatment for OUD in the ED.

NCT06494904.

Although several systematic reviews and meta-analyses have demonstrated the benefits of exercise interventions in older adults with frailty, the potential harm associated with these interventions has not been systematically synthesised. This systematic review aims to examine the adverse events reported in exercise intervention trials involving older adults with frailty and to compare the risk of adverse events between the intervention and control groups.

Searches will be performed in four electronic databases (PubMed, Cochrane Library, Web of Science and SPORTDiscus) for published trials. Eligible studies will be randomised controlled trials of exercise interventions, including older adults with frailty aged ≥60 years, with frailty identified using a validated method. Five reviewers and three referees, all with expertise in exercise interventions, will be assigned to three independent review teams to ensure efficient screening. Reviewers will independently screen titles, abstracts and full texts using Rayyan, and then extract trial and adverse event data into an Excel spreadsheet. The risk of bias in eligible trials will be assessed using the Cochrane Risk of Bias 2 (RoB-2) tool. The referees will resolve any disagreements between the two reviewers throughout the screening, data extraction and risk-of-bias assessment processes. The primary outcome is adverse events, defined as any unfavourable, unintended signs, symptoms or disease that occurred during the study period. An independent biostatistician will perform a random-effects meta-analysis using a generalised linear mixed model with a binomial likelihood and a logit link to estimate the pooled risk ratios (RRs) for adverse events in the intervention group relative to the control group. Publication bias will be evaluated using funnel plots and Egger’s regression test. Depending on the number of available studies, subgroup analyses will be conducted to examine differences in RRs according to the study quality, duration of intervention, exercise frequency, setting and supervision.

Ethical approval was not required because we did not use specific patient data. The findings of the systematic review and meta-analysis will be disseminated through publication in a peer-reviewed journal and presentation at appropriate conferences.

CRD420251180645.

To examine whether the use of a venous access-site closure device is associated with the occurrence of postoperative nausea and vomiting (PONV) after atrial fibrillation (AF) ablation under propofol sedation.

Observational study.

A single-centre retrospective observational study in Okayama, Japan.

We retrospectively analysed consecutive patients who underwent AF ablation under deep propofol sedation with adaptive servo-ventilation. A total of 686 patients were included. Patients were managed using a standardised sedation protocol with or without low-dose pentazocine. Patients treated with conventional manual compression for haemostasis (n=383) were compared with those treated using a venous access-site closure device (n=303).

Postprocedural bed rest duration and the incidence and timing of PONV were compared between groups. Associations between closure device use and PONV were evaluated using logistic regression analysis.

The primary outcome was the occurrence of PONV following AF ablation.

All procedures were completed under propofol sedation without conversion to general anaesthesia. The duration of postprocedural bed rest was shorter in the device group than in the conventional-compression group (mean difference –14.7 hours, 95% CI –15.2 to –14.0).

PONV occurred in 6/303 patients (2.0%) in the device group and 20/383 patients (5.2%) in the conventional-compression group, corresponding to a relative risk of 0.38 (95% CI 0.15 to 0.93), an OR 0.25 (95% CI 0.10 to 0.62) and a risk difference of –3.2% (95% CI –6.0% to –0.5%).

In multivariable analysis, use of a venous closure device was associated with a lower likelihood of PONV.

In this single-centre observational study, use of a venous access-site closure device was associated with a lower occurrence of PONV after AF ablation under propofol sedation. These findings suggest that postprocedural management strategies enabling earlier mobilisation may be associated with improved patient comfort; however, causal inference is limited by the observational design.

To explore healthcare professionals’ perspectives on the potential role of molecular breast imaging (MBI) for breast cancer imaging and to inform future clinical study design and implementation.

Qualitative interview study.

UK National Health Service (NHS) breast screening and diagnostic pathways.

Purposively sampled stakeholders.

Semistructured interviews with key professional stakeholders explored potential MBI pathways and routes to adoption, including barriers and facilitators. Data were analysed thematically.

22 participants were recruited between January 2020 and October 2021. Barriers to MBI adoption were identified at three levels: scan-related, system-level, and cultural within the screening programme. Overcoming these is likely necessary for implementation. A further theme highlighted the potential for MBI to improve screening in selected patient groups, contingent on addressing these barriers. Specifically, adoption would require advances in next-generation MBI systems, particularly reductions in radiation dose and scan time, alongside prospective clinical studies in UK populations to assess diagnostic accuracy.

Once identified barriers are overcome, participants perceived that MBI could improve screening pathways, particularly for women with dense breast tissue.

Patient engagement is the practice of "meaningful and active collaboration [of patient partners] in governance, priority setting, conducting research and knowledge translation." Patient engagement has been implemented in various settings including clinical, research, and quality improvement, with varying levels of patient contributions and decision-making responsibility. However, little is known about the experiences of patient partners who are in leadership roles in patient-led events. For Patients, By Patients (PxP) is an annual, virtual, patient-led conference that focuses on topics important to patient partners in research. Each year’s PxP steering committee is comprised of those with patient experiences and consequently, offers an opportunity for our research team to explore patient leadership within a conference setting. Understanding more about the intricacies of patient-led events is necessary if we wish to support patient leadership as a valuable form of patient engagement.

The aim of this study was to explore (1) the benefits and challenges experienced by PxP steering committee members in a patient-led event and (2) how to better support patient leadership.

We conducted a qualitative descriptive study of semi-structured virtual interviews with PxP conference steering committee members. Thematic analysis was used to identify core themes that were salient to the data.

The Canadian Institutes of Health Research-Institute of Musculoskeletal Health and Arthritis in Vancouver, Canada, and an international virtual setting via Zoom from January 2025 to April 2025.

Purposive sampling was used to conduct interviews with thirteen PxP patient partner steering committee members.

Four core themes were identified in the data: (1) institutional support: how institutions can support patient leadership, (2) steering committee environmental characteristics: what characteristics are conducive to patient leadership, (3) personal growth: how patient leadership promotes growth among patient partners and (4) new possibilities: how patient-led events foster future expansion and opportunities. Power dynamics, intersectionality, and accessibility were also identified as central to supporting patient leadership and building safe and supportive environments.

Patient partners are capable of leading events which promote interpersonal relationships and advance patient engagement practices and governance. Important facilitators include institutional support and governance that considers power dynamics, accessibility and intersectionality.

Our aim was to compare the incidence and outcomes of civil legal cases in Canada involving international medical graduate (IMG) physicians to physicians who graduated from medical schools in Canada or the US.

We conducted a retrospective cohort study with multilevel, multivariate modelling of civil legal cases against physicians licensed to practise in Canada.

We used the Canadian Medical Protective Association’s national repository of medicolegal case data.

We extracted data on physicians’ demographic characteristics, geographical characteristics and undergraduate medical education.

Outcomes included physician medicolegal case rates (the number of civil legal actions a physician is involved in per year) and case outcomes (when a case proceeds and is either dismissed, settled or proceeds to trial). Our multilevel models examined associations between physician factors and the rate of civil legal actions and the distribution of civil legal outcomes.

The case rate model included 433 038 physician-year observations from 98 960 physicians (2015–2019), with 7657 civil legal cases (mean case rate per physician-year 0.0221; 98% had no cases). Case rates did not differ significantly between IMGs and Canadian/US graduates (p=0.0516). The case outcome model included 8046 cases (2016–2023). Unadjusted, cases favoured the plaintiff slightly more often for IMGs (39.1% vs 36.6%, ² (2, N=8046)=14.03, p

Our study suggests that where physicians receive their medical degree has no effect on their level of medicolegal risk in civil legal actions in Canada.

Diabetes mellitus is a highly prevalent metabolic disorder associated with chronic, low-grade inflammation. Of recent interest is the association between diabetes and circadian rhythm disruption. The aim of this review is to evaluate and synthesise clinical evidence for whether diabetes affects homeostatic diurnal patterns to proinflammatory markers in the human body. This could inform the optimal timing of immune-targeted therapies over the course of the day.

This systematic review will include primary clinical research studies reporting on diurnal variations, defined as an afternoon/evening (PM) minus a morning (AM) value, within a timeframe of 12±4 hours, for predefined proinflammatory markers, in individuals with diabetes (type 1 or type 2) compared with healthy controls. A search of online databases (Cochrane CENTRAL, Ovid MEDLINE and Ovid Embase) will be performed. Grey literature searches will be performed in clinical trial registries. Two review authors will independently screen retrieved citation records at the title/abstract and full-text levels. Study quality will be assessed using an appropriate National Institute of Health quality assessment tool. A meta-analysis will be performed if more than one study reports equivalent data for any outcome. Statistical heterogeneity will be assessed using the ² test. Where a meta-analysis is not possible or unlikely to be meaningful, a narrative synthesis of the findings will be provided.

Ethics approval is not required for this systematic review as no original data will be collected. The results will be disseminated through peer-reviewed publication and conference presentations.

CRD420251115780.

To identify factors influencing unnecessary non-sterile glove use in operating theatres and to estimate how common these factors are across the UK.

Mixed-methods study using interviews and a cross-sectional survey.

Imperial College Healthcare Trust for interviews and nationally across the UK for the survey.

19 interviewees and 329 survey respondents, all clinical staff working in UK operating theatres.

Barriers and facilitators to unnecessary non-sterile glove use in operating theatres.

The findings highlight a combination of key drivers leading to the unnecessary use of non-sterile gloves: (1) lack of prioritisation of sustainability, (2) fears around negative patient outcomes, (3) strong social influences such as norms to use gloves, (4) the absence of clear guidelines and limited training on glove use, (5) availability of alternatives and quality of gloves and (6) beliefs about personal safety and habitual glove use. Respondents also suggested potential intervention strategies.

67% of participants reported using gloves unnecessarily. Our findings highlight the role of habitual behaviour, social influences and unclear guidelines in driving this practice. Interventions should address these factors, for example, by clearly communicating when gloves should and should not be worn, encouraging changes to local social norms towards waste reduction, improving access to hand gel and supporting habit change to reduce unnecessary glove use and associated environmental impact.

To investigate the prevalence of depression, anxiety and stress among primary caregivers of children with childhood-onset systemic lupus erythematosus (cSLE) in China and to explore their psychosocial correlates based on the stress process model.

A cross-sectional study.

3 tertiary public hospitals in Hunan Province, China.

242 primary caregivers were invited, and 211 completed the study (87.2% response rate). Convenience sampling was used. Eligible participants were unpaid adult caregivers (aged ≥18 years) of children (aged 1 month. Exclusion criteria included inability to complete questionnaires independently, cognitive impairment due to major physical or mental disorders and current participation in other psychological interventions.

Primary outcomes (depression, anxiety and stress) were measured using the Depression Anxiety and Stress Scale-21. Correlates included threat/challenge appraisal, coping style and perceived social support.

Among 211 caregivers (mean age 40.55±8.22 years; 77.3% female), 31.8% reported depression, 27.0% anxiety and 24.2% stress. Higher threat appraisal was consistently associated with depression (regression coefficients (B) =1.012, p

Caregivers of children with cSLE face substantial psychological distress, with threat perception and negative coping as key modifiable correlates. Interventions to reshape cognitive appraisal and promote adaptive coping, alongside expanded health insurance coverage and optimised caregiving role distribution, are needed to alleviate caregiver burden.

Patient safety is crucial in healthcare, especially in home-based settings where unregulated environments and limited supervision pose unique challenges. With the expansion of home healthcare due to an ageing population and healthcare workforce shortages, there is a pressing need for tools to assess patient safety culture in this context. Current instruments, developed for hospitals, do not adequately address the specific dynamics of home healthcare, such as patient autonomy and caregiver involvement. This protocol outlines the development and validation of the Patient Safety Culture in Home Health Care Centers Instrument (PSCHCI), using a sequential exploratory mixed-methods approach.

This sequential exploratory mixed-methods protocol consists of three phases. Phase 1 fieldwork (semi-structured interviews with 15 participants, 3 participant observations and field notes) has been completed. Qualitative data are currently being analysed using conventional content analysis. The scoping review component of Phase 1 is planned but has not yet been conducted. Phase 2 (instrument development) is planned to include item generation from qualitative results followed by expert panel review. Phase 3 (psychometric evaluation), scheduled for late 2026, will employ a cross-sectional study to assess face, content and construct validity; reliability; interpretability; and feasibility. This phase features pilot testing (n=30–50), face and content validity assessment (n=10 each), test-retest reliability (n=15) and exploratory and confirmatory factor analyses (n=300–400).

Ethical approval was obtained from the Ethics Committee of Iran University of Medical Sciences. All participants will provide written informed consent. Confidentiality, voluntary participation and withdrawal rights are guaranteed. Findings will be published in peer-reviewed journals, presented at conferences and shared with participating home healthcare centres, policymakers and stakeholders.

Intracerebral haemorrhage (ICH) accounts for approximately 15% of all strokes in Denmark and remains associated with high mortality and morbidity. It is challenging to distinguish neoplastic from non-neoplastic causes of ICH in the acute setting, and CT findings that may aid early differentiation have not been fully characterised. Existing ICH-classification systems (SMASH-U, H-ATOMIC and CLAS-ICH) have not been directly compared for diagnostic accuracy in this setting. Identifying radiological and clinical factors associated with underlying aetiology may support faster diagnosis, reduce time to workup related to potential underlying cancer and facilitate early targeted treatment of the underlying cause of ICH.

This study is a retrospective observational cohort including all patients admitted with acute ICH to the Department of Neurology, University Hospital of Southern Denmark, Aabenraa between January 2014 and December 2024 (estimated approximately n=610). Medical records and initial non-enhanced CT scans will be reviewed. Two neurologists and two radiologists, blinded to final diagnosis, will independently extract clinical presentation, topographical and volumetric haemorrhage characteristics, and classify each case using the abovementioned ICH-classification systems. Primary analyses will assess associations between clinical and radiological features and underlying neoplastic vs non-neoplastic aetiology. Secondary analyses will compare diagnostic performance of classification systems using sensitivity, specificity and receiver operating characteristic curves. Multivariate logistic regression models will be applied with Holm correction for multiple comparisons.

The study has been submitted to the National Danish Research Ethics Committee and the Danish Data Protection Agency. As data derive from completed disease courses, no patient contact is expected. Results will be disseminated through peer-reviewed journals, conferences and scientific presentations.

Cytoreductive surgery (CRS) with heated intraperitoneal chemotherapy (HIPEC) is a treatment for peritonitis carcinomatosa. These procedures often involve significant blood and fluid loss, leading to hyperdynamic circulation and vasodilation, necessitating intraoperative fluids and vasoconstrictors such as catecholamines. Excessive fluid administration to counteract vasodilation can cause intraoperative fluid overload, which is linked to increased postoperative complications. Vasopressin has emerged as a potential alternative to catecholamines, restoring vascular tone via non-adrenergic pathways and supporting perfusion pressure, potentially reducing the need for compensatory fluids solely administered to compensate for vasodilation. We hypothesise that compared with norepinephrine, vasopressin reduces cumulative intraoperative fluid administration during CRS-HIPEC within a goal-directed fluid therapy (GDFT) protocol, ultimately leading to a lowering of postoperative complications.

HiPress is a two-centre, two-arm randomised clinical trial with blinding of both patients and outcome assessors. A total of 70 adult patients undergoing CRS-HIPEC will be included. Patients will be randomised to receive either continuous low-dose argipressin or continuous low-dose norepinephrine. Both groups will receive standardised GDFT during the procedure. The primary endpoint is cumulative intraoperative fluid administration (mL). Secondary endpoints include direct fluid-related outcomes (eg, cumulative intraoperative fluid (ml/kg/hour), postoperative fluid balance until day five and ultrasound-assessed pulmonary oedema and venous congestion) and indirect fluid-associated outcomes (eg, quality of recovery, surgical and abdominal complications, acute kidney injury (AKI), pulmonary complications, length of ICU and hospital stay and 30-day mortality).

The study is enrolling patients since February 2025. The trial is approved by the Medical Research Ethics Committee (hereinafter: MREC) NedMec, The Netherlands (Ref: D-25-500202). Results of the trial will be published in an international peer-reviewed journal and announced at national and international scientific meetings.

Clinical Trials Information System (CTIS): European Union clinical trials register (EUCT) number: 2024–5 13 598-33-00

The progressive adaptation of the maternal cardiovascular system throughout pregnancy is essential to maintaining adequate uteroplacental circulation and meeting maternal physiological demands. In recent years, maternal haemodynamic parameters have gained attention as useful indicators for screening and managing pregnancy, particularly for identifying women at high risk for complications and predicting adverse pregnancy outcomes. The aim of this study is to assess the trajectory of haemodynamic parameters during labour, establish reference ranges for different stages of labour and explore the association between haemodynamics and adverse pregnancy outcomes.

This is an ambispective observational cohort study conducted in a tertiary hospital in Chongqing, China. A total of 2800 pregnant women will be enrolled. After hospital admission and providing written informed consent, participants will complete a demographic questionnaire. Data collection will include maternal baseline characteristics, haemodynamic parameters at multiple stages of labour and maternal and newborn outcomes. These data will allow comprehensive analysis of haemodynamic changes during labour in women undergoing vaginal delivery.

This study has been approved by the Research Ethics Committee of the First Affiliated Hospital of Chongqing Medical University (ethics approval number: 2024–406-01). Participation is voluntary and initiated only after obtaining written informed consent. The findings will be disseminated through presentations at national and international conferences and through publications in peer-reviewed scientific journals.

ChiCTR2500097643.

The establishment of an effective strategy for recurrence prevention following curative treatment for hepatocellular carcinoma (HCC), including radiotherapy, remains a critical unmet clinical need. Despite favourable local control and safety profiles, recurrence after particle therapy remains a major challenge, highlighting the need for effective adjuvant strategies to improve long-term outcomes. The present phase Ib/II trial is designed to evaluate the safety and efficacy of atezolizumab plus bevacizumab (Atezo+Bev) administered after carbon-ion radiotherapy (C-ion RT) in patients with unresectable non-metastatic large HCC. This study aims to explore the potential of this multimodal approach as a novel adjuvant strategy to improve outcomes in patients at high risk of recurrence.

This is a phase Ib/II, single-arm clinical trial designed to evaluate the safety and efficacy of adjuvant Atezo+Bev following C-ion RT in patients with HCC. Eligible patients will be enrolled in the first registration phase. C-ion RT (60 Gy) will be administered over four consecutive treatment days ideally within one calendar week. Patients will receive a combination of atezolizumab (1200 mg) and bevacizumab (15 mg/kg) administered intravenously every 21 days for one treatment cycle. The primary endpoint of the phase Ib part is the proportion of patients with dose-limiting toxicity (DLT). DLT is defined as prespecified toxicities associated with the investigational drug among the adverse events that occurred from the start date of the investigational drug (Day 1) to Day 21. If there is one or fewer cases of DLT out of six cases, the trial will proceed to the phase II part. The primary endpoint of the phase II part is the 1-year recurrence-free survival rate.

This study was approved by the ethics committee of two participating institutions (Chiba University Hospital (approval No. 2024021) and National Institute for Quantum and Radiological Science and Technology, QST Hospital (approval No. C24-001)). Trial results will be reported in a peer-reviewed journal publication.

jRCT2031240284.